System for Preparing and Making Available a Flowable Medium Formed By Mixing a Dry Substance With a Fluid

ABSTRACT

System for preparing and making available a flowable medium that is formed by mixing a dry substance with a fluid. A system for preparing and making available a flowable medium ( 43 ) that is formed by mixing a dry substance ( 39 ) with a fluid ( 41 ), in particular a medium for therapeutic purposes, comprises the following system components: a) a first container ( 1 ), which receives the fluid ( 41 ) and has a wall part ( 3 ) that is able to deform counter to a restoring force in order to change the container volume; b) a second container ( 35 ) receiving the dry substance ( 39 ), and c) a transfer device ( 21 ) for producing a fluid communication between the first container ( 1 ) and the second container ( 35 ).

The invention relates to a system for preparing and making available aflowable medium formed by mixing a dry substance with a fluid, inparticular a medium for therapeutic purposes.

Fluid media which are intended, for example, for therapeutic purposes oralso for other purposes must often be freshly prepared close to the timethey are actually to be used, because only the components which form themedium are inherently stable and/or storable enough, but not theultimately prepared medium. In practical applications therefore it isoften necessary to store a dry substance and a fluid separately from oneanother until the use of the medium formed from a mixture of the drysubstance and the fluid is imminent.

Generally the procedure followed here is such that the fluid, forexample, a solvent, is taken up by means of a hypodermic needle andinjected into a container which contains the dry substance. Afterwardsthe resulting solution is removed with a new syringe in order to beapplied or administered in the desired manner; in therapeuticapplications this can take place, for example, by injection, placementas an additive in an infusion container or the like.

Such application processes, in which injection needles are used, entailthe risk that injuries can occur. This circumstance is extremelyproblematical when working in an environment in which the presence ofHIV viruses can be expected.

In this respect, the object of the invention is to make available asystem for preparing and making available a flowable medium which isformed by mixing a dry substance with a fluid, which is characterized byimproved handling safety.

This object is achieved by a system which has the features of claim 1 inits entirety.

Because, according to the invention, there is a transfer device as theadditional system component, the fluid exchange between the containersinvolved which is necessary for preparing and making available themedium takes place in a closed operating process, i.e., without separatehandling of the individual containers themselves and drawing up asyringe from one container and injection of the withdrawn fluid into theother container having been necessary. Because the first container whichholds the pertinent fluid has a wall part which can be deformed againsta restoring force, the fluid from the first container can be forced byway of a transfer device into the second container which holds the drysubstance so that in the latter container the dry substance is mixedwith the fluid. When this has taken place, the deformable wall part ofthe first container is released, so that as a result of the restoringforce acting on the first container its volume increases again and thusthe prepared medium is intaken by way of the transfer device into thefirst container in which now the completely prepared medium is ready foruse. The system according to the invention enables not only safehandling without the risk of injury, but, moreover, as a result of theclosed operating process also offers special protection againstcontamination.

Preferably the wall part which can be deformed against the restoringforce is formed by a bellows which has an inherent restoring forceagainst deformation. This container is preferably an ampule-like plasticcontainer which is produced using the known Bottelpack® molding processand is filled with the pertinent fluid, and whose wall is provided withfolds and is designed bellows-like such that it can be compressed in theaxial direction in order to express the enclosed fluid. Such a bellows,which is formed from a suitable plastic material after the compressiveforce acting on it is removed, returns to its original shape in whichthe volume of the container is returned to its original size.

Preferably the first container for its connection to the transfer deviceon one end of the bellows can have a head part which is preferablymolded onto the bellows in one piece, on the head part there being catchmeans for forming a catch with the catch means which are present on anassigned connecting means of the transfer device.

Preferably the arrangement can be such that the head part has a central,projecting connection piece whose end is normally closed by a removableclosure part, preferably a twist-off toggle which is integral with theconnection piece.

The catch means of the head part can be formed by arms which areintegral with the head part and which extend along the outside of theconnection piece with the formation of an intermediate space; on thefree end regions of the arms catch bodies are molded which project inthe direction to the connection piece and on which there are recessedcatch notches.

In such a configuration of the head part and of the catch means of thefirst container, the connecting means of the transfer device assigned tothis container can have a hollow connecting shank which, in order toform a plug connection with the connection piece of the first container,has an end-side widening as a seat for holding the connection piecewhich extends with its outside wall surface into the intermediate spacebetween the arms which form the catch means of the head. In anespecially simple manner, when the plug connection is formed by theholder of the connection piece of the first container in the seat of thehollow connecting shank of the transfer device, a fluid-tight connectionis formed with simultaneous mechanical connection by the interactingcatch means.

As catch means which are provided on the connecting means of thetransfer device there can be catch projections which are molded onto theouter wall surface of the connecting shank and which interact with thecatch notches on the arms of the head part and thus ensure the plugconnection which has been formed in this way.

In advantageous embodiments the transfer device in an extension of theconnecting shank has a through channel whose end section as a componentof the connecting means of the transfer device which is intended for thesecond container is formed by a projecting cannula, via which at thesame time a fluid connection can be produced with the second containerwhich contains the dry substance when the second container has a closurewhich can be penetrated by the cannula. Containers such as these,preferably in the form of small-volume glass bottles, are standard.

In especially advantageous embodiments, an additional system componentcan be a device which facilitates and simplifies joining the transferdevice and the second container in the positional relationship which isprovided for penetration of the closure by the cannula. For this purposethere can be a sleeve body which is open on one end and which on theother end has an end plate with a central through opening for thecannula of the transfer device, the sleeve body being designed such thatit forms a guide for the second container which can be inserted into thesleeve body from the open end in the direction to the cannula. Toimplement the connection process, therefore the second container, forexample, in the form of a small-volume glass bottle of the conventionaltype, need simply be pushed into the sleeve body after the transferdevice has been inserted beforehand into the sleeve body through thecentral through opening of the end plate. This ensures that when thecontainer is pushed into the sleeve body the cannula penetrates thecentral region, i.e., the region of the closure of the second containerwhich can be penetrated.

In this configuration of the sleeve body, at the same time it forms aprotective jacket of the inserted cannula. Although this cannula, incontrast to conventional injection needles, does not pose a significantinjury risk, an additional improvement of handling safety is achieved bythe jacketing.

The subject matter of the invention is also a container which isintended for use in the system according to the invention and ischaracterized by the features specified in claim 12.

According to claim 16, another subject matter of this invention relatesto the use of a system according to one of claims 1 to 11 and acontainer according to one of claims 12 to 15 for preparing and makingavailable a flowable medium.

The invention will be detailed below using the drawings.

FIG. 1 shows a side view of a bellows ampule which is intended as thefirst container of the system, shown approximately in natural size,

FIG. 2 shows a detached view of only the region of the ampule from FIG.1 adjacent to its head part, conversely turned 90° around thelongitudinal axis of the ampule;

FIG. 3 shows a partial view solely of the region of the connecting pieceprovided with a Luer connection on the head part of the bellows ampule,which region is identified with arrow III in FIG. 1, and which view isshown detached and greatly enlarged relative to FIGS. 1 and 2;

FIG. 4 shows a representation of one embodiment of the system accordingto the invention drawn in a longitudinal section, the system componentssuch as the bellows ampule from FIG. 1 being shown as a first container,a transfer device and a glass bottle as the second container being shownin positions pulled apart from one another;

FIG. 5 shows a representation which corresponds to FIG. 4, but thesystem components being shown in the assembled position and in a statewhich corresponds to a first working step of the operating sequence;

FIG. 6 shows a partial longitudinal section solely of the regiondesignated as VI in FIG. 5, which is detached and greatly enlargedcompared to FIG. 5;

FIGS. 7A, 7B and 7C show representations of the system which are similarto FIG. 5, the operating states which correspond to a second, third andfourth step of the operating sequence being shown;

FIG. 8 shows a side view which is slightly enlarged relative to apractical embodiment, in which the second container, a sleeve body whichis used as a connecting device, and only the end section of the transferdevice which is adjacent to the second container are shown, and

FIG. 9 shows a view corresponding to FIG. 8 in a representation whichhas been turned 90° relative thereto.

FIG. 1 shows a bellows ampule which is designated as a whole as 1 in theclosed state which forms a component of the system according to theinvention which is to be described here as the first container. Theampule 1 together with the bellows 3 which forms its actual receivingspace, a head part 5 which adjoins it as a closure part, and with atwist-off toggle 7 which closes its outlet opening 9 (FIG. 3) isproduced using the known Bottelpack® process from plastic in one pieceand is filled with a fluid. The plastic material used for production hasa certain elastic property so that when the twist-off toggle 7 isremoved, the bellows 3 can be compressed in the axial direction so thatby a respective reduction of the volume the contained fluid can beexpressed from the opening 9 (FIG. 3) on the connection piece 11. If thebellows 3 is released, due to the restoring force which is dictated byits elasticity it returns to the original shape shown in FIG. 1, theinterior of the bellows 3 again having the initial volume.

FIG. 3 shows the outside shape of the connection piece 11 of the headpart 5, its being apparent that on the end region which is located onthe opening 9 there is a Luer connection 13. As is likewise apparentfrom the figures, arms 15 are molded onto the head part 5 on both sidesof the connection piece 11 and extend in the axial direction at adistance from the outside of the connection piece 11. In the vicinity ofthe end edges of these arms 14 there are recessed catch notches 17 whichare intended for locking with a catch rib 19 which is located on atransfer device 21 which is used as another component of the system.Locking occurs when, proceeding from the operating state shown in FIG.4, the twist-off toggle 7 of the bellows ampule 1 is removed and as thenext step of the operating sequence a plug connection to the transferdevice 21 is established, as is shown in FIG. 5. Details of the plugconnection produced with the transfer device 21 are illustrated in FIG.6 on a larger scale which shows the region identified with VI in FIG. 5.As is to be seen, the connection piece 11 in this instance is located onthe head part 5 within a widened seat 23 in a hollow connection shank 25of the transfer device 21, the connection piece 11 being suitably heldin the seat 23, i.e., sealed. As is likewise apparent most clearly fromFIG. 6, the catch rib 19 is located on the outside of the shank 25 inthe vicinity of its free end. The arms 15 which have the catch notches17 extend proceeding from the head part 5 over the outside of the shank25 to above the catch rib 19 which snaps into the notches 17.

FIGS. 5, 7A, 7B, and 7C illustrate the continuing operating sequence inthe use of the system according to the invention. As is apparent, thetransfer device 21 in an extension of the seat 23 of the connectingshank 25 has an axial through channel 29 which extends through athickened region 31 which forms a stop shoulder 32 (FIG. 4) and ends inan axially projecting cannula 33. A glass bottle 35 which acts as thesecond container of the system with a closure 37 which can be penetratedby a cannula 33 can be placed on the stop shoulder 32 so that the end ofthe cannula 33 extends into the interior of the bottle 35. When this isthe case, and when a plug connection has been established between thebellows ampule 1 and the transfer device 21, by compressing the bellows3 the fluid in the ampule 1 is expressed and forced into the bottle 35by way of the transfer device 21. For preparing the medium to beproduced, in the initial state which is shown in FIG. 4 the bottlecontains, for example, a dry substance 39 to which the fluid, forexample, a solvent 41, see FIG. 5, is added.

FIG. 7A shows as the next step the operating state in which after mixingthe dry substance 35 with the solvent 41 the prepared medium 43 is inthe bottle 35. In order to return the prepared medium from the bottle 35by way of the transfer device 21 to the bellows ampule 1 so that theprepared medium is made available in it, as is shown in FIG. 7B, it ispossible to proceed such that the system is turned around, whereupon, asis shown in FIG. 7C, the compressed bellows 3 is now released so thatdue to the increase of its volume the medium 43 is sucked back out ofthe bottle 35 into the bellows ampule 1, see FIG. 7C. After releasingthe plug connection with the transfer device 21 the prepared medium isnow made available in the ampule 1.

FIGS. 8 and 9 show a version of the system, there being a connectiondevice in order to bring the bottle 35 which forms the second containereasily and comfortably into defined alignment with the transfer device21. One particular feature of the device is that at the same time itforms a protective jacket for the cannula 33 of the transfer device 35,as is apparent from FIGS. 8 and 9. These figures show that the bottle 35with the cannula inserted is surrounded by the sleeve body 45 in theform of a hollow cylinder which is open on the end facing away from thetransfer device 21, so that the bottle can be pushed into the sleevebody 45 in the axial direction from the open end and can be moved into aposition in which the cannula 33 enters the bottle 35. The sleeve body45 on the end which lies on the stop shoulder 32 of the transfer device21 has an end plate 44 which surrounds the central through opening forthe cannula 33.

As FIGS. 8 and 9 moreover show, in the wall of the sleeve body 45notches 59 are cut out which extend elastically into the interior of thejacket 45. When the bottle 35 is pushed into the sleeve body 45, thesewall parts on the bottle neck snap in behind the top part of the bottle61 so that the bottle 35 which has been pushed into the sleeve body 45is secured in position. The sleeve body 45 is preferably molded from atransparent plastic material so that when the system is being used theprocess of mixing of the fluid 41 and the dry substance can be visuallyobserved.

1. A system for preparing and making available a flowable medium (43)formed by mixing a dry substance (39) with a fluid (41), in particular amedium for therapeutic purposes, with the following system components:a) a first container (1) which holds the fluid (41) with a wall part (3)which can be deformed against a restoring force to change the volume; b)a second container (35) which holds the dry substance (39) and c) atransfer device (21) for producing a fluid connection between the first(1) and second container (35).
 2. The system according to claim 1,wherein the wall part of the first container (1) which can be deformedagainst the restoring force is formed by a bellows (3) which has aninherent restoring force against deformation.
 3. The system according toclaim 2, wherein the first container (1) for its connection to thetransfer device (21) on one end of the bellows (3) has a head part (5)on which catch means (15, 17) are provided for forming a catch with thecatch means (19) which are present on an assigned connecting means (23,25) of the transfer device (21).
 4. The system according to claim 3,wherein the head part (5) has a central, projecting connection piece(11) whose end is normally closed by a removable closure part,preferably a twist-off toggle (7) which is integral with the connectionpiece (11).
 5. The system according to claim 4, wherein the catch meansof the head part (5) are formed by arms (15) which are integral with thehead part and which extend along the outside of the connection piece(11) with the formation of an intermediate space, on the free endregions of the arms catch bodies are molded which project in thedirection to the connection piece (11) and on which there are recessedcatch notches (17).
 6. The system according to claim 5, wherein theconnecting means of the transfer device (21) assigned to the firstcontainer (1) has a hollow connecting shank (25) which, in order to forma plug connection with the connection piece (11) of the first container(1), has a end-side widening (23) as a seat for holding the connectionpiece (11), the connection shank (25) extending with its outside wallsurface into the intermediate space between the arms (15) which form thecatch means (17) of the head part (5).
 7. The system according to claim6, wherein on the outer wall surface of the connecting shank (25) thereis a catch rib (19) as the catch means of the transfer device whichinteracts with the catch notches (17) of the arms (15) of the head part(5).
 8. The system according to claim 6, wherein the transfer device(21) in an extension of the connecting shank (25) has a through channel(29) whose end section as a component of the connecting means of thetransfer device (21) which is intended for the second container (35) isformed by a projecting cannula (33).
 9. The system according to claim 8,wherein the second container (35) has a closure (37) which can bepenetrated by the cannula (33).
 10. The system according to claim 9,characterized by a device (44, 45) for joining the transfer device (21)and the second container (35) in a positional relationship which isintended for penetration of the closure (37) by the cannula (33). 11.The system according to claim 10, wherein the device has a sleeve body(45) which is open on one end and on the other end has an end plate (44)with a central through opening for the cannula (33) of the transferdevice (21) and wherein the sleeve body (45) forms a guide for thecontainer (35) which can be inserted into the sleeve body (45) from theopen end in the direction to the cannula (33).
 12. A container (1) for asystem according to claim 1, wherein it has a wall part which can bedeformed against the restoring force and which is formed by a bellows(3) which has an inherent restoring force against deformation.
 13. Thecontainer according to claim 12, wherein the container (1) for itsconnection to the transfer device (21) on one end of the bellows (3) hasa head part (5) on which there are catch means (15, 17) for forming acatch with the catch means (19) which are present on an assignedconnecting means (23, 25) of the transfer device (21).
 14. The containeraccording to claim 13, wherein the head part (5) has a central,projecting connection piece (11) whose end is normally closed by aremovable closure part, preferably a twist-off toggle (7) which isintegral with the connection piece (11).
 15. The container according toclaim 14, wherein the catch means of the head part (5) are formed byarms (15) which are integral with the head part and which extend alongthe outside of the connection piece (11) with the formation of anintermediate space, on the free end regions of the arms catch bodies aremolded which project in the direction to the connection piece (11) andon which there are recessed catch notches (17).
 16. Use of a systemaccording to claim 1 and a container according to one of claims 12 to 15for preparing and making available a flowable medium (43), in particulara medium for therapeutic purposes, by applying a compressive force tothe deformable wall part (3) of the first container (1) its volume beingreduced and the fluid (41) thus being forced into the second container(35) via the transfer device (21) and after mixing of the fluid (41)with the dry substance (39) located in the second container (35) theapplication of a compressive force to the deformable wall part (3) beingended so that due to the increase in volume which is caused by therestoring force of the wall part (3) the medium (43) is intaken into thefirst container (1) and is made available in it for use.